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A Multicenter RCT of "3+7" vs Venetoclax + CACAG in Newly Diagnosed Mid/High-Risk AML Patients
RECRUITINGPhase 2Sponsored by Chinese PLA General Hospital
Actively Recruiting
PhasePhase 2
SponsorChinese PLA General Hospital
Started2024-04-18
Est. completion2026-04-18
Eligibility
Age14 Years – 75 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06928376
Summary
The purpose of this study is to compare the efficacy and safety of venetoclax combined with the CACAG regimen with the traditional "3+7" regimen in the treatment of newly diagnosed intermediate- or high-risk acute myeloid leukemia (AML).
Eligibility
Age: 14 Years – 75 YearsHealthy volunteers accepted
Inclusion Criteria: Age 14 to 75 years (no gender limitation) Newly diagnosed with intermediate- or high-risk AML (excluding M3) Liver function: ALT and AST ≤ 2.5 times upper limit of normal; bilirubin ≤ 2 times upper limit of normal Renal function: creatinine ≤ upper limit of normal No uncontrolled infections, organ dysfunction, or severe mental illness ECOG performance status score of 0-2 and predicted survival ≥ 4 months No severe allergic constitution Exclusion Criteria: Allergy or contraindication to the study drug Pregnant or breastfeeding female patients Known history of alcohol or drug addiction (due to potential non-compliance) Mental illness or conditions preventing protocol compliance Less than 6 weeks after major organ surgery Liver function: ALT and AST \> 2.5 times upper limit of normal; bilirubin \> 2 times upper limit of normal Renal function: creatinine \> upper limit of normal Deemed unsuitable for the clinical trial (poor compliance, substance abuse, etc.) \-
Conditions3
Acute Myeloid LeukemiaCancerFirst Line Therapy
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Actively Recruiting
PhasePhase 2
SponsorChinese PLA General Hospital
Started2024-04-18
Est. completion2026-04-18
Eligibility
Age14 Years – 75 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06928376